Devices for Monitoring Movement of a Secured Catheter During a Procedure

ABSTRACT

A device for securing and monitoring movement of a catheter includes a film having an adhesive disposed on a body-facing surface for securing the film to a body. The device also includes a base mounted on the film, the base comprising a first portion of a guide channel for receiving the catheter. A cover is coupled to the base via a hinge, the cover comprising a second portion of the guide channel, the cover further comprising a rounded portion extending from a distal end of the cover, wherein in the closed configuration, the catheter is completely enclosed by the rounded portion and the first and second portions of the guide channel. The device also includes a positional shift indicator fixedly attached to the catheter and configured to indicate positional shifts by the catheter within the guide channel.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation application of U.S. patentapplication Ser. No. 16/626,652, entitled “Devices for MonitoringMovement of a Secured Catheter During a Procedure” and filed on Dec. 26,2019, which is a 371 National Stage application of PCT/US2018/040572,entitled “Device with Open Cutout Design for Securement and PositionVerification of Medical Catheters” and filed on Jul. 2, 2018, which, inturn, claims priority to, and the benefit of, U.S. Provisional PatentApplication entitled, “Medical Devices for Placing and SecuringCatheters,” having Ser. No. 62/528,219, filed on Jul. 3, 2017, all ofwhich are incorporated by reference in their entirety.

TECHNICAL FIELD

The present disclosure generally relates to medical devices and moreparticularly, to an antimicrobial, securement, and position verificationdevice for medical catheters.

BACKGROUND

Medical catheters are invaluable tools in the medical field. However,infections associated with inadvertent positional shifts of cathetersare a major source of morbidity and mortality for patients. Healthcareproviders are also unable to assess positional changes in catheterswithout utilizing radiographic imaging. This exposes the patient tounnecessary radiation and is also financially costly. While devicesexist that individually address catheter associated problems, the use ofmultiple devices is cumbersome and inefficient in the healthcareprocess.

SUMMARY

Briefly described, one embodiment, among others, is a device forsecuring and monitoring movement of a catheter. The device comprises afilm having an adhesive disposed on a body-facing surface for securingthe film to a body. The device also comprises a base mounted on thefilm, the base comprising a first portion of a guide channel forreceiving the catheter, the base further comprising a tab memberprotruding from a side of the base. The device also comprises a hingecoupled to the base, the hinge extending along a longitudinal directionof the base. The device also comprises a cover coupled to the base viathe hinge such that the cover is operable to pivot about the hinge froman open configuration to a closed configuration, the cover comprising asecond portion of the guide channel, the cover further comprising arounded portion extending from a distal end of the cover, wherein in theclosed configuration, the catheter is completely enclosed by the roundedportion and the first and second portions of the guide channel. In theclosed configuration, the cover and the base form a housing for securingthe catheter, wherein an adhesive is disposed on the first and secondportions of the guide channel for restricting movement of the catheter,wherein the cover further comprises a positional shift indicator fixedlyattached to the catheter and configured to indicate positional shifts bythe catheter within the guide channel, wherein the positional shiftindicator comprises a plurality of segments arranged in a directionperpendicular to a longitudinal direction of the cover.

Another embodiment is a method for securing and monitoring movement of acatheter utilizing a device comprising a film, a base, and a covercoupled to the base via a hinge. The method comprises attaching the filmto a body, the film having an adhesive disposed on a body-facing surfacefor securing the film to the body. The method further comprisesinserting the catheter at a catheter entry point into a body and placingthe catheter in a first portion of a guide channel in the base forreceiving the catheter, the base further comprising a tab memberprotruding from a side of the base. The method further comprisespivoting the cover coupled to the base via the hinge such that the coveris placed into a closed configuration with respect to the base, thecover comprising a second portion of the guide channel, the coverfurther comprising a rounded portion extending from a distal end of thecover. In the closed configuration, the catheter is completely enclosedby the rounded portion and the first and second portions of the guidechannel. In the closed configuration, the cover and the base form ahousing for securing the catheter, wherein an adhesive is disposed onthe first and second portions of the guide channel for restrictingmovement of the catheter, wherein the cover further comprises apositional shift indicator fixedly attached to the catheter andconfigured to indicate positional shifts by the catheter within theguide channel, wherein the positional shift indicator comprises aplurality of segments arranged in a direction perpendicular to alongitudinal direction of the cover.

Another embodiment is a device for securing and monitoring movement of acatheter. The device comprises an oval-shaped film having an adhesivedisposed on a body-facing surface for securing the film to a body, thefilm having a cutout portion extending from an edge of the film to acentral portion of the film. The device further comprises a tapered basemounted on the film, the base comprising a first portion of a guidechannel for receiving the catheter, the base further comprising arectangular tab member protruding from a side of the base. The devicefurther comprises a hinge coupled to the base, the hinge extending alonga longitudinal direction of the base. The device further comprises atapered cover coupled to the base via the hinge such that the cover isoperable to pivot about the hinge from an open configuration to a closedconfiguration, the cover comprising a second portion of the guidechannel, the cover further comprising a semi-circular member extendingfrom a distal end of the cover, wherein in the closed configuration, thecatheter is completely enclosed by the semi-circular member and thefirst and second portions of the guide channel. In the closedconfiguration, the cover and the base form a housing for securing thecatheter, wherein an adhesive is disposed on the first and secondportions of the guide channel for restricting movement of the catheter,wherein the cover further comprises a positional shift indicator fixedlyattached to the catheter and configured to indicate positional shifts bythe catheter within the guide channel, wherein the positional shiftindicator comprises a plurality of segments arranged in a directionperpendicular to a longitudinal direction of the cover.

Other systems, methods, features, and advantages of the presentdisclosure will be or become apparent to one with skill in the art uponexamination of the following drawings and detailed description. It isintended that all such additional systems, methods, features, andadvantages be included within this description, be within the scope ofthe present disclosure, and be protected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the present disclosure. Moreover, in thedrawings, like reference numerals designate corresponding partsthroughout the several views.

FIG. 1 illustrates a top plan view of the device while in an openconfiguration according to various embodiments.

FIG. 2 illustrates a perspective view of the device in FIG. 1 accordingto various embodiments.

FIG. 3 illustrates a side view of the device in FIG. 1 in the directionof view arrows 3-3 while in an open configuration according to variousembodiments.

FIG. 4 illustrates a perspective view of the device in FIG. 1 while in aclosed configuration according to various embodiments.

FIG. 5 illustrates a top plan view of the film of the device in FIG. 1according to various embodiments.

FIG. 6 illustrates a top plan view of an alternative embodiment of thedevice with a cutout in the base for insertion of a biomedical sensoraccording to various embodiments.

FIG. 7 illustrates a perspective view of the device in FIG. 6 accordingto various embodiments.

FIG. 8 illustrates a perspective view of an alternative embodiment ofthe device with stabilizer members in the base according to variousembodiments.

DETAILED DESCRIPTION

Medical catheters are invaluable tools in the medical field. However,the use of catheters can present certain challenges. Typically, uponinitial placement of a catheter, a healthcare provider applies anadjuvant antimicrobial barrier device at the site of catheter insertion.A secondary adjuvant device is then applied over the medical catheter tosecure the catheter position. Significantly, the use of multipleadjuvant devices in conjunction with a medical catheter is inefficientand increases the risk of malfunction and subsequent harm to thepatient. Furthermore, healthcare providers are unable to assesspositional shifts of a medical catheter without utilizing a radiographicstudy, which is expensive and exposes the patient to unnecessaryradiation.

Various embodiments are described for incorporating an improvedsecurement device utilized in conjunction with medical catheters. Byutilizing the device disclosed herein, healthcare providers are able toaddress the problems of catheter associated infections, cathetersecurement, and detection of inadvertent catheter positional shifts in asingle device, thereby simplifying the utilization of a medicalcatheter. In accordance with various embodiments, the device isconfigured as a single adjuvant to medical catheters and attaches at theentry point of the catheter to the skin. For some embodiments, thedevice fully covers the catheter entry site while securing the catheterto prevent any positional shifts. Indicators are implemented on thedevice, which alert healthcare providers of any positional shifts by thecatheter that may have occurred. Notably, a single device is disclosedthat provides antimicrobial protection, securement against positionalshifts, and the ability to alert healthcare providers of inadvertentpositional shifts without the need for additional radiographic studies.

Reference is made to FIG. 1, which illustrates a top plan view of thedevice 100 while in an open configuration according to variousembodiments. The device 100 comprises a film 102 having an adhesivedisposed on a body-facing surface for securing the film 102 to a body.For some embodiments, multiple components of the device 100 may haveantimicrobial properties either intrinsically or coated with variousantimicrobial substance. For example, the body-facing surface of thefilm 102 may have antimicrobial properties. The device 100 includes abase 104 mounted on the film 102, where the base 104 includes a firstportion 106 of a guide channel for receiving a catheter. Specifically, afirst portion 106 having a semi-circular cross section is formed in thebase 104.

The device 100 further comprises a hinge 110 coupled to the base 104. Acover 112 is coupled to the base 104 via the hinge 110 such that thecover 112 is operable to pivot about the hinge 110 to transition from anopen configuration to a closed configuration where the cover 112 comesin contact with the base 104. As shown, the base 104 further comprises atab member 108 that protrudes from a side of the base 104. For someembodiments, the tab member 108 is a rectangular structure and isaligned with a bottom edge of the base 104. The tab member 108facilitates initial application of the device 100 to the body byallowing a medical professional to press down on the tab member 108while placing the device 100 into the closed configuration. The tabmember 108 is also utilized to create a fulcrum to facilitate removal ofthe device 100.

For some embodiments, the cover 112 and the base 104 are eachconstructed of a clear medical grade silicone material. The cover 112further comprises a second portion 114 of the guide channel. As with thefirst portion 106 of the guide channel in the base 104, the secondportion 114 has a semi-circular cross section and is formed in the cover112. In the closed configuration, the first portion 106 and the secondportion 114 form a guide channel with a circular cross section fordirecting the catheter to a catheter entry point into the body. For someembodiments, the guide channel has a diameter that is approximately thesame diameter of the catheter being inserted into the body. The guidechannel is also operable for securing the catheter and alerting medicalprofessionals of any positional shifts, as described in more detailbelow. For some embodiments, an adhesive is disposed on the first andsecond portions 106, 114 of the guide channel for restricting movementof the catheter.

The cover 112 further comprises a rounded portion 116 that extends froma distal end of the cover 112. FIG. 2 illustrates a perspective view ofthe device 100 while in an open configuration according to variousembodiments. As shown, a recess region 202 is formed in the roundedportion 116 such that an outer c-shaped seal 204 is formed on theperimeter of the rounded portion 116. FIG. 3 illustrates a side view ofthe device 100 in FIG. 1 in the direction of view arrows 3-3 while in anopen configuration. When placed in the closed configuration, the roundedportion 116 forms an enclosure with the base 104 such that the catheter302 is completely enclosed by the rounded portion 116 and the first andsecond portions 106, 114 of the guide channel.

Referring back to FIG. 1, the cover 112 includes a positional shiftindicator 118 configured to indicate positional shifts by the catheterwithin the guide channel where the positional shift indicator 118 isfixedly attached to the catheter. For some embodiments, the positionalshift indicator 118 comprises multiple segments 118 a, 118 b, 118 c,where the segments 118 a, 118 b, 118 c are arranged in a side-by-sideconfiguration extending in a lateral direction (H) of the cover 112.Specifically, the segments 118 a, 118 b, 118 c are arranged in adirection perpendicular to a longitudinal direction (L) in which thesecond portion 114 of the guide channel extends in the cover 112. Notethat the configuration of segments 118 a,118 b, 118 c may changedepending on the intended application where the individual segments 118a,118 b, 118 c may be static or may move in relation to the catheter.Additionally the segments 118 a, 118 c adjacent to the center segment118 b may be placed in various configurations in relation to theadhesive film placed on the base 104 and the cover 112 depending on theintended application.

As shown, the first portion 106 of the guide channel in the base 104includes a region 120 wider than a remainder of the first portion 106.Similarly, the second portion 114 of the guide channel in the cover 112includes a region 122 wider than a remainder of the second portion 114.For some embodiments, one of the plurality of segments 118 a, 118 b, 118c is disposed within the region 122 of the second portion 114 in thecover. Specifically, a center segment 118 b among the plurality ofsegments 118 a, 118 b, 118 c may be disposed within the region 122 ofthe second portion 114, where the wider region 122 functions as a windowfor the positional shift indicator 118 and alerts medical professionalsof any positional shifts in the catheter. FIG. 4 illustrates aperspective view of the device in FIG. 1 while in a closedconfiguration. Due to construction of the cover 112 from clear medicalgrade silicone or other suitable material, the positional shiftindicator 118 attached to the catheter is viewable from a top viewthrough a top surface of the cover 112 while the device 100 is in theclosed configuration.

The device 100 may be constructed using medical grade silicone rubbers,plastics, fabrics, or other suitable materials. The type ofantimicrobial substance used in the device 100 may also be varied toaddress specific microorganisms or conditions. It should be noted thatthe dimensions and orientation of individual or assembled components maybe varied for use with different types of medical catheters. Similarlythe positional shift indicator 118 may be altered to adapt to differenttypes of catheters. Additionally, certain aspects of individualcomponents can potentially be altered to meet dimensional orenvironmental conditions present during the usage of the catheter.

Referring back to FIG. 1, the first portion 106 of the guide channel inthe base 104 includes a notch 124 at a distal end of the first portion106 of the guide channel. The notch 124 functions as a catheter entrypoint for insertion of the catheter into the body. As shown, the notch124 is disposed over a cutout portion of the film 102. The open cutoutdesign of the film 102 is described in more detail below. The secondportion 114 of the guide channel includes a recess 126 in the cover 112at a distal end of the second portion 114. In the closed configuration,the recess 126 and the notch 124 allow the catheter to enter the bodywhile the cover 112 forms a complete seal over the catheter.

The cover 112 further comprises a second film 128 having an adhesivedisposed on a body-facing surface for securing the second film 128 tothe body. The second film 128 is attached to and extends from therounded portion 116 of the cover 112. As shown in FIG. 4, in the closedconfiguration, the second film 128 is disposed over the cutout region ofthe film 102 to form a complete seal around the catheter entry pointinto the body.

FIG. 5 illustrates the open cutout design of the film 102 of FIG. 1. Forsome embodiments, the film 102 includes a cutout portion 502 thatextends from an edge of the film to a central portion of the film 102.The circular region 504 of the cutout portion 502 allows a medicalprofessional to apply dressing containing an antiseptic agent at thecatheter entry point to reduce the possibility of infection. Oneadvantage of the open cutout design of the film 102 is that this designallows a medical professional to easily insert the catheter through theguide channel of the device 100 (FIG. 1) and directly into the catheterentry point of the body while the device 100 is in the openconfiguration.

In contrast, a continuous film design (i.e., one where there is nocutout in the film) would require a medical professional to thread thecatheter through a slit or hole cut in the film 102. Alternatively, theentire device 100 would have to be open on one side, thereby potentiallyexposing part of the catheter entry point. In contrast, the open cutoutdesign of the film 102 allows for easy insertion of the catheter. In theclosed configuration, the second film 128 (FIG. 1) and the roundedportion 116 (FIG. 1) of the cover 112 (FIG. 1) cover the cutout portion502 of the film 102, thereby providing a complete seal around thecatheter entry point.

FIG. 6 illustrates a top plan view of an alternative embodiment of thedevice 100 with a recess 602 in the base 104 for insertion of abiomedical sensor (not shown) in the base 104 near the catheter entrypoint according to various embodiments. As shown in the perspective viewprovided in FIG. 7, the recess 602 in the base 104 may comprise adisc-shaped recess. For some embodiments, the recess 602 is embeddedwithin the base 104 and is not accessible from the top surface of thebase 104 that comes in contact with the cover 112. In other embodiments,however, the recess 602 is disposed on a top surface of the base 104 (asshown in FIG. 7). In this regard, the recess 602 may be disposed on thebottom surface of the base 104 where the sensor comes in contact withthe skin or disposed on a top surface of the base 104. For otherembodiments, the recess 602 may be disposed on either a top surface or abottom surface of the cover 112. That is, the recess 602 can be disposedanywhere in either the base 104 or the cover 112, depending on theintended functionality of the sensor.

Note that although the FIG. 6 illustrates a disc-shaped recess 602 forplacement of a biomedical sensor within the base 104, the recess 602 isnot limited to this shape. Specifically, the shapes of the recess andthe spatial relationship of the sensor in regard to the base 104 orcover 112 may vary depending on the intended sensor functionality. Thesensor may be localized in a variety of locations within the device 100depending on functionality of the sensor.

Due to the location of the recess 602 in the base 104, a biometricsensor may be placed proximal to the catheter entry site to facilitatedetection of biofeedback signals relevant to catheter infection onproximal portion of the catheter. Such biofeedback signals may indicate,for example, temperature change, color change of the skin, detection ofbiologic antigens/chemical substances attributable to pathogenicorganisms, and so on. A biometric sensor may be placed proximal to thecatheter entry site to facilitate detection of biofeedback signalsrelevant to catheter dislodgement or movement where such biofeedbacksignals may comprise, for example, pressure signals, tension signals,kinematic signals, and so on. A biometric sensor may be placed proximalto the catheter entry site to facilitate detection of biofeedbacksignals relevant to catheter functionality of proximal portion ofcatheter where such biofeedback signals may comprise, for example,pressure signals, optical signals relevant to pulse-wave variationswithin the catheter, and so on. The biometric sensor may be isolated infunctionality or may be part of a network of similarly connectedmonitors and/or feedback devices.

The biometric sensor used in conjunction with the device (FIG. 6) mayinclude a variety of sensor types depending on the intended application.The biometric sensor can have stand-alone functionality or bepotentially connected to other related Internet of things network.Sensors and integrated components can potentially collect a variety ofdata including skin and device temperature, skin and device colorchanges, skin and device moisture levels, presence or absence ofspecific healthcare related antigens/chemicals (e.g., microorganism bioproducts), motion and kinematic data, physiologic data, and so on.Additionally biometric sensors may collect data outside of informationrelated to catheter functionality and in regards to the patient orenvironment as a whole.

FIG. 8 illustrates a perspective view of an alternative embodiment ofthe device 100 with stabilizers 802 a, 802 b in the base 104 of thedevice 100. The stabilizers 802 a, 802 b provide increased stabilizationof the device 100 upon placement of the device 100 onto the body. Thestabilizers 802 a, 802 b also facilitate correct parallel alignmentbetween the catheter entry point and the body. Additionally the lengthof the stabilizers 802 a, 802 b may vary depending on the intendedfunctionality of the device 100. For example, in cases where additionalstabilization is needed, the stabilizers 802 a, 802 b may have increasedlength in proportion to the base 104. Corresponding components such asadhesives necessary to adhere the stabilizers 802 a, 802 b may alsochange depending on the intended use.

It should be emphasized that the above-described embodiments are merelyexamples of possible implementations. Many variations and modificationsmay be made to the above-described embodiments without departing fromthe principles of the present disclosure.

At least the following is claimed:
 1. A device for securing andmonitoring movement of a catheter, comprising: a film having an adhesivedisposed on a body-facing surface for securing the film to a body; abase mounted on the film, the base comprising a first portion of a guidechannel for receiving the catheter, the base further comprising a tabmember protruding from a side of the base; a hinge coupled to the base,the hinge extending along a longitudinal direction of the base; a covercoupled to the base via the hinge such that the cover is operable topivot about the hinge from an open configuration to a closedconfiguration, the cover comprising a second portion of the guidechannel, the cover further comprising a rounded portion extending from adistal end of the cover, wherein in the closed configuration, thecatheter is completely enclosed by the rounded portion and the first andsecond portions of the guide channel; wherein in the closedconfiguration, the cover and the base form a housing for securing thecatheter, wherein an adhesive is disposed on the first and secondportions of the guide channel for restricting movement of the catheter,wherein the cover further comprises a positional shift indicator fixedlyattached to the catheter and configured to indicate positional shifts bythe catheter within the guide channel, wherein the positional shiftindicator comprises a plurality of segments arranged in a directionperpendicular to a longitudinal direction of the cover.
 2. The device ofclaim 1, wherein the cover and the base are constructed of a clearmedical grade silicone material.
 3. The device of claim 1, wherein thepositional shift indicator fixedly attached to the catheter is viewablefrom a top view through a top surface of the cover.
 4. The device ofclaim 1, wherein a center segment of the plurality of segments of thepositional shift indicator is disposed on the second portion of theguide channel in the cover.
 5. The device of claim 1, wherein the secondportion of the guide channel in the cover includes a region wider than aremainder of the second portion of the guide channel in the cover,wherein the center segment is disposed in the region.
 6. The device ofclaim 1, wherein the film includes a cutout portion extending from anedge of the film to a central portion of the film.
 7. The device ofclaim 6, wherein the first portion of the guide channel in the baseincludes a notch at a distal end of the first portion of the guidechannel for insertion of the catheter into the body, wherein the notchis disposed over the cutout portion of the film.
 8. The device of claim6, wherein the cover further comprises a second film having an adhesivedisposed on a body-facing surface for securing the second film to thebody, the second film being attached to and extending from the roundedportion of the cover, wherein in the closed configuration, the secondfilm is disposed over the cutout portion to form a complete seal.
 9. Thedevice of claim 1, wherein the base further comprises a recessimplemented on a surface of one of the base or the cover for placementof a biomedical sensor.
 10. The device of claim 1, wherein an adhesiveis disposed on a surface of the cover and on a surface of the base thatcome into contact with one another in the closed configuration.
 11. Amethod for securing and monitoring movement of a catheter utilizing adevice comprising a film, a base, and a cover coupled to the base via ahinge, the method comprising: attaching the film to a body, the filmhaving an adhesive disposed on a body-facing surface for securing thefilm to the body; inserting the catheter at a catheter entry point intoa body and placing the catheter in a first portion of a guide channel inthe base for receiving the catheter, the base further comprising a tabmember protruding from a side of the base; pivoting the cover coupled tothe base via the hinge such that the cover is placed into a closedconfiguration with respect to the base, the cover comprising a secondportion of the guide channel, the cover further comprising a roundedportion extending from a distal end of the cover, wherein in the closedconfiguration, the catheter is completely enclosed by the roundedportion and the first and second portions of the guide channel; whereinin the closed configuration, the cover and the base form a housing forsecuring the catheter, wherein an adhesive is disposed on the first andsecond portions of the guide channel for restricting movement of thecatheter, wherein the cover further comprises a positional shiftindicator fixedly attached to the catheter and configured to indicatepositional shifts by the catheter within the guide channel, wherein thepositional shift indicator comprises a plurality of segments arranged ina direction perpendicular to a longitudinal direction of the cover. 12.The method of claim 11, wherein the step of pivoting the cover coupledto the base via the hinge such that the cover is placed into a closedconfiguration with respect to the base is performed while insertingforce on the tab member.
 13. The method of claim 11, wherein the filmincludes a cutout portion extending from an edge of the film to acentral portion of the film.
 14. The method of claim 13, wherein thefirst portion of the guide channel in the base includes a notch at adistal end of the first portion of the guide channel for insertion ofthe catheter into the body, wherein the notch is disposed over thecutout portion of the film.
 15. The method of claim 13, furthercomprising attaching a second film over the cutout portion to form acomplete seal, where the second film is attached to and extends from therounded portion of the cover, the second film having an adhesivedisposed on a body-facing surface for securing the second film to thebody.
 16. The method of claim 11, further comprising: while the deviceis in the closed configuration, monitoring for a positional shift of anyof the plurality of segment of the positional shift indicator.
 17. Adevice for securing and monitoring movement of a catheter, comprising:an oval-shaped film having an adhesive disposed on a body-facing surfacefor securing the film to a body, the film having a cutout portionextending from an edge of the film to a central portion of the film; abase having tapered sides, the base mounted on the film, the basecomprising a first portion of a guide channel for receiving thecatheter, the base further comprising a rectangular tab memberprotruding from a side of the base; a hinge coupled to the base, thehinge extending along a longitudinal direction of the base; a coverhaving tapered sides, the cover coupled to the base via the hinge suchthat the cover is operable to pivot about the hinge from an openconfiguration to a closed configuration, the cover comprising a secondportion of the guide channel, the cover further comprising asemi-circular member extending from a distal end of the cover, whereinin the closed configuration, the catheter is completely enclosed by thesemi-circular member and the first and second portions of the guidechannel; wherein in the closed configuration, the cover and the baseform a housing for securing the catheter, wherein an adhesive isdisposed on the first and second portions of the guide channel forrestricting movement of the catheter, wherein the cover furthercomprises a positional shift indicator fixedly attached to the catheterand configured to indicate positional shifts by the catheter within theguide channel, wherein the positional shift indicator comprises aplurality of segments arranged in a direction perpendicular to alongitudinal direction of the cover.
 18. The device of claim 17, whereina portion of the cutout portion located in the central portion of thefilm extends under the base.
 19. The device of claim 17, wherein thecover further comprises a second film having an adhesive disposed on abody-facing surface for securing the second film to the body, the secondfilm being attached to and extending from the semi-circular member ofthe cover, wherein in the closed configuration, the second film isdisposed over the cutout portion to form a complete seal.
 20. The deviceof claim 17, wherein the base further comprises stabilizers, each of thestabilizers located on a tapered side of the base.